Kornimate/medical-research-clean huggingface dataset:
inetetamab combined with paclitaxel with/without pertuzumab for previously treated her2-positive advanced breast cancer

Conditions: Breast Cancer Stage IV

Summary: this study is designed to comprehensively evaluate the her2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of inetetamab and paclitaxel ± pertuzumab, including basic characteristics, efficacy and safety. the results of this study are helpful to further understand the efficacy and safety of her2 positive patients with recurrent/metastatic breast cancer who receive the combination of inetetamab and paclitaxel ± pertuzumab in the first line, and help clinical decision-making.


Eligibility criteria:
inclusion criteria: 1. age 18 - 70 years, female 2. patients with her2-positive breast cancer defined as immunohistochemical (ihc) test + + +, or fish test positive 3. participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent inoperable or radiological evidence of metastatic disease 4. have not received first-line anti-her2 treatment or (neo) adjuvant anti-her2 drug treatment that is effective and has been discontinued for more than 12 months 5. patients with assessable target lesion as per recist 1.1 and irrecist criteria; 6. ecog ps score 0 or 1, estimated survival time ≥3 months, and can be followed-up; 7. the cardiopulmonary function is basically normal, with lvef ≥ 50%; 8. adequate organ function; 9. female patients of childbearing age who have negative pregnancy tests and voluntarily adopt effective and reliable contraceptive measures； 10. the patient voluntarily signs an informed consent form. exclusion criteria: 1. participated in other clinical trials within 4 weeks; 2. have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage); 3. during the (neo) adjuvant phase, other anti-her2 treatments were received in addition to trastuzumab and pertuzumab; 4. patients who experience disease progression during (neo) adjuvant trastuzumab treatment, as well as patients who experience recurrence/metastasis within 12 months after completing (neo) adjuvant system treatment; 5. evidence of central nervous system metastasis or leptomeningeal disease; 6. individuals with a known history of allergies to the components of this medication regimen; 7. pregnant or lactating women; 8. left ventricular ejection fraction\<50% for cardiac function; patients with obvious clinical manifestations such as arrhythmia, myocardial ischemia, severe atrioventricular block, heart dysfunction, and severe heart valve disease; 9. the researchers believe that it is not appropriate to participate in this trial, as any other medical, social, or psychological factors may affect safety or compliance with research procedures.
diuretics vs. afterload reduction for treatment of heartlogic alerts

Conditions: Heart Failure, Congestive

Summary: the dart-ha study is a single-center, open label, trial intended to evaluate the clinical efficacy of standard treatment options for congestive heart failure (observation, diuretic or afterload reduction therapy) in patients without new symptoms who have developed abnormalities of the heartlogic heart failure diagnostic feature.

subjects with congestive heart failure (chf) who have undergone implantation of a boston scientific pacemaker/defibrillator with a heartlogic sensor will be remotely monitored for for elevation of their heartlogic score which is indicative of worsening heart failure. subjects whose devices demonstrate heartlogic score elevations and also do not demonstrate symptoms from heart failure will be randomized to observation or one of two standard treatments for worsening heart failure, afterload reduction or diuretic therapy. subjects will be followed to assess the change in heartlogic score, incidence of the the heartlogic score returning to normal levels, the development of symptoms of heart failure and/or the need for treatment for heart failure.

Eligibility criteria:
inclusion criteria: * boston scientific device with heartlogic enabled * lack of standard contraindications to sacubitril/valsartan: * history of ace-inhibitor induced angioedema and in those with angiotensin ii receptor blocker (arb) therapy induced angioedema. * hypotension, hypovolemia * renal artery stenosis, renal failure * hyperkalemia * hepatic disease child-pugh class c * pregnancy/breast-feeding * lack of standard contraindications to diuretic therapy * systolic blood pressure \> 105 exclusion criteria: * glomerular filtration rate \<25 ml/min who are non-responsive to diuretic therapy or are on chronic renal dialysis * ongoing symptoms of heart failure decompensation (increased dyspnea and/or fatigue, for purposes of this study increased weight is not considered, see question 2 kccq). * recent significant change in arrhythmia burden (within the past 2 weeks) * in cardiac resynchronization therapy (crt) patients, recent change (60 days) in effective delivery of crt (eg. decreased biventricular paving %) * the subject is unable to sign or refuses to sign the patient informed consent * symptomatic heart failure at rest or new york heart association class iv at the time of enrollment * the subject is implanted with unipolar right atrial or right ventricular leads * subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months * subject is pregnant or planning to become pregnant during the study * regularly scheduled iv heart failure therapy (e.g. inotropes or diuretics)
drug interaction study of saxagliptin in combination with dapagliflozin in healthy participants

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate whether the pharmacokinetics (body concentrations/metabolism of the drug) of saxagliptin and dapagliflozin are affected when they are administered together


Eligibility criteria:
inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ecg, and clinical laboratory determinations * body mass index (bmi) of 18 to 30 kg/m2 * men and women, ages 18 to 45 years * women of childbearing potential must use acceptable methods of highly effective birth control exclusion criteria: * history of chronic or recurrent urinary tract infection for females * history of allergies or adverse reactions to dipeptidyl peptidase-iv (dpp4) or sodium-glucose transporter type 2 (sglt2) inhibitors * any significant acute or chronic medical illness * current or recent gastrointestinal disease * any major surgery within 4 weeks of study drug administration * prior exposure to saxagliptin or dapagliflozin or related drugs
artificial intelligence performance in colonoscopy in daily practice

Conditions: Colonic Polyp; Adenoma

Summary: randomized, controlled single center, single investigator study mainly in colorectal screening population in daily practice with and without artificial intelliegence (ai) named discoverytm from pentax medical. patient randomly are allocated to one of four groups: pentax i10 colonoscopes without any additional device, pentax i 10 with discoverytm (ai), pentax i 10 with endocufftm and pentax i10 with endocufftm and discoverytm (ai). the different groups are compared in terms of the different parameters: e.g. time of endoscopy, polyps (pdr) and adenoma detected (adr).

from august 2021 through august 2022 all patients undergoing a colonoscopy in a gastroenterologist's private practice are assigned using randomization tables to one or the other above mentioned groups. time of the endoscopy (ascent, descent and intervention time), polyps detected and their histology are written down real time with a tablet computer anonymized with the patient number. furthermore dosage of sedatives and over all satisfaction is traced. 1. endpoint is time gain in the different phase of the colonoscopy 2. endpoint is adenoma detection rate (adr)

Eligibility criteria:
inclusion criteria: * all patients referred and fit for an ambulant colonoscopy exclusion criteria: * none

Keywords: artificial intelligence
analysis of heart rate variability during emergency flight simulator missions in fighter pilots

Conditions: Heart Rate Variability; Autonomic Nervous System

Summary: the autonomous response of fighter and attack pilots who attend sessions in a flight simulator will be evaluated by measuring and analyzing heart rate variability (hrv).

the autonomous response of fighter and attack pilots during emergency situations in a flight simulator will be assessed by measuring and analysing heart rate variability (hrv). eighteen pilots with instructor or student status assigned at the time of the evaluation to the ala 23 district of the talavera la real air base of the ministry of defence of the spanish government (badajoz) were studied during emergency situations in flight simulator. subjects were assigned by non-probabilistic randomisation to an instructor group (ig; 7 subjects), and to a student group (ag; 11 subjects). the recording of the parameters indicated corresponds to the emergency situations described above. data collection was made in three different moments: 1. take-off: it starts after reading the checklist until the engine fault is resolved. 2. flight: during manoeuvres characterised by the recovery of abnormal positions. 3. landing: where the pilot performs the landing manoeuvre, with the loss of spatial situation.

Eligibility criteria:
inclusion criteria: * pilots who had the status of instructor or student assigned at the time of assessment to the ala 23 district of the talavera la real air base of the ministry of defense of the government of spain (badajoz). exclusion criteria: * any uncontrolled neurological or cardiac disorder. * being involved in ongoing medical-legal conflicts.

Keywords: emergency missions assesment military health services heart rate variability autonomic nervous system
precise local injection of anti-cancer drugs using presage's civo device in soft tissue sarcoma

Conditions: Soft Tissue Sarcoma Adult

Summary: this is a feasibility study in patients with localized or metastatic soft tissue sarcoma undergoing surgery to determine how sarcoma in situ responds to injected microdoses of anti-cancer therapeutics.

this is a single arm, pilot study designed to test the feasibility of using the civo (comparative in vivo oncology) system in patients with soft tissue sarcoma accessible for percutaneous injection. patients who are scheduled for surgical biopsy or tumor resection surgery will be injected 4 to 72 hours prior to surgery using the civo device. minute volumes (up to 8.3 microliters) of saline (negative control) or microdoses of anti-cancer agents will be percutaneously injected in a columnar fashion through each of 8 needles into a single solid tumor. following the patient's biopsy surgery or tumor resection surgery, the injected portion and a small uninjected portion will be used to determine the in situ drug response in the tumor. none of the data from this evaluation will be shared with patients or used to make clinical decisions. study clinicians will have access to the patient's health record for 1 year after the study to monitor patient treatment responses. such information will be used to help evaluate the correlation between clinical response and tumor response assessed via civo.

Eligibility criteria:
inclusion criteria: * 18 years of age or over. * at least one suspected soft tissue sarcoma tumor that is considered by the investigator to be: (1) accessible for percutaneous injection and (2) at least 2.5 cm in shortest dimension for patients undergoing an incisional biopsy, or at least 3 cm in shortest dimension for patients undergoing an excisional biopsy/tumor resection. tumors should not be selected if the investigator believes them to be necrotic or exhibit signs of radiation-induced fibrosis. * prior surgical evaluation and plan for surgical biopsy or surgery to remove the tumor being injected. * ecog performance status of 0-2 (or a karnofsky performance status of \>50%) * labs required for enrollment (prior to microinjection): * absolute neutrophil count \> 1000/mm3 * platelet count \> 50,000/mm3 * hematocrit \> 25% * creatinine \<3.0 mg/dl * total bilirubin \<4.0 mg/dl * bilirubin \<4.0 mg/dl, sgot ≤ 1.5 times the upper limit of normal * pt and ptt ≤ 1.5 times the upper limit of normal exclusion criteria: * subjects with active fungal, viral, or bacterial infections. * pregnant women. * inability to give informed consent. * current treatment with anticoagulation such as warfarin or low-molecular-weight heparin. * tumors near critical structures such as those located near or in the brain or spine. this assessment will be determined by the treating clinician.

Keywords: in vivo drug sensitivity personalized medicine precision oncology in vivo oncology soft tissue sarcoma chemotherapy microinjection microdosing tumor microenvironment multiplexed immunohistochemistry
translational-omics in aortic stenosis (tomas) biobank

Conditions: Cardiovascular Diseases; Aortic Valve Stenosis

Summary: the objective of the tomas biobank is the conservation of biological material (plasma, saliva, and tissue explanted during surgery), genetic material (dna, rna, etc.), and clinical data ("material/data") collected from patients with cardiovascular diseases (cvd) as well as from control participants, in order to allow future studies evaluating novel proteomic, transcriptomic and epigenomic markers (as well as other emerging -omic technologies) for cvd (i.e. aortic stenosis, cardiomyopathy, myorcardial infarction, etc). the study of physiological and genetic factors will allow for the discovery of new genomic and other -omic (including proteomic, transcriptomic and epigenomic) biomarkers associated with cvd which will lead to an improved understanding of the underlying biology of cvd and may provide future insights into the prevention and treatment of this type of disease.

inherited from parents, dna is organized into genes and is unique to each individual. genes contain the information that dictates how cells function and hence, can also influence the risk of developing diseases. due to the uniqueness and variability between each individual, genes can confer different risks of developing diseases when comparing one person to another person (or a group of people). when a biological product can be measured to predict whether someone is at a higher risk for a certain disease, it is called a "biomarker". biomarkers include, but are not limited to genetic material (such as dna) and certain proteins found in the heart and the blood. by studying genes and proteins isolated from biological samples (blood, saliva and heart tissue), investigators of this biobank hope to characterize known biomarkers, identify novel biomarkers and ultimately, improve the diagnosis and treatment of heart diseases. the purpose of this research is to: (1) perform a genetic study of cardiovascular diseases, such as aortic valve diseases and (2) create a biobank (that will include blood samples, genetic material, and tissue explanted at surgery) to be used for analysis in the future.

Eligibility criteria:
inclusion criteria: * cvd diagnosis including, but not limited to: aortic stenosis, coronary heart disease, heart failure, atrial fibrilation, dilated cardiomyopathy, myocardial infarction, and spontaneous coronary artery dissection. * undergoing cardiac surgery for non-aortic valve pathology exclusion criteria: * individuals with congenital heart disease will be excluded
evaluation of adjunctive endoanchors for evar and tevar

Conditions: Aortic Aneurysm; Thoracic Aortic Aneurysm

Summary: endoanchors (heli-fx device, medtronic, santa rosa) have beed described to improve fixation (mimicking an open surgical anastomosis) during or after evar/tevar. the investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study)

endoanchors (heli-fx device, medtronic, santa rosa) have beed designed to improve the endovascular aortic repair. this device is described to mimic an open surgical anastomosis during or after evar/tevar. the investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study), these outcomes will be described in terms of type ia endoleaks, migration and sac regression.

Eligibility criteria:
inclusion criteria: * all consecutive patients with adjunctive use of endoanchors during or after evar and tevar exclusion criteria: * patients that don't want te receive any repair for their disease

Keywords: endoanchors evar tevar
brightpoint reflectometer device study

Conditions: Epidural Placement

Summary: participants are being asked to participate in this study because they are having an epidural placed for labor. this human clinical trial has been designed to evaluate the use of the brightpoint reflectometer device (aka brightpoint device) as secondary confirmation of loss of residence (lor) for lumbar epidural placement by an experienced clinician. for this study, participants will be randomized to receive an epidural by an experienced clinician either with or without the use of the brightpoint device. epidurals performed as a part of this study will be done in a manner similar to how epidurals are currently performed in the hospital. the epidural space will be entered using usual loss of resistance technique for all patients. if the brightpoint device is used, it will be as secondary verification of entry into the epidural space.


Eligibility criteria:
inclusion criteria: * any patient undergoing an epidural procedure exclusion criteria: * previous lumbar spine surgery * any known spinal abnormality that would interferre with successfully advancing a needle into the epidural space * any subject that requires an epidural needle longer than 4.0 inches * any procedure requiring use of cse needles * any contraindication to neuraxial anesthesia * no subjects in advanced active labor, e.g., 6-8 cm dilated * tattoo at the site of epidural insertion

Keywords: labor epidural
convalescent plasma for patients with covid-19

Conditions: Coronavirus Infection; Coronavirus; COVID

Summary: pilot study of tolerability and efficacy of transfusion of 200ml of convalescent plasma in patients with covid-19 respiratory disease.

importance: convalescent plasma has been shown to be safe in patients with covid-19, but whether it is clinically effective in patients with severe covid-19 pneumonia is still unclear. objective: to evaluate the safety, tolerability, efficacy, and adverse events related to transfusion of convalescent plasma in patients hospitalized with severe or critical covid-19 pneumonia. design, setting and participants: randomized, single center, open-label, controlled trial of patients hospitalized between may 1, 2020, and august 1, 2020, with severe covid-19 pneumonia in 1 tertiary care health system in the united states. a total of 30 participants age ≥ 18 years with 1 or more of the following were enrolled: dyspnea; respiratory rate \> 30; o2 saturation ≤ 93%; pao2/fio2 or sao2/fio2 ratio \ 50% within 24 to 48 hours. intervention: transfusion with 1 unit of abo compatible convalescent plasma in addition to standard care (n = 20) or standard care (n = 10). standard care included steroids. main outcomes and measures: primary outcome was improvement in oxygenation 72 hours after infusion measured by change in arterial blood gas or in pao2/fio2 or sa/fio2. secondary outcomes were mortality at 28 days, days on mechanical ventilation, intensive care unit and hospital length of stay, and msofa score.

Eligibility criteria:
inclusion criteria: * age \> 18 with one or more of the following: dyspnea respiratory rate \>= 30 breaths/min oxygen saturation \<=93% pao2/fio2 \<300 bilateral airspace opacities on chest radiograph at 24 to 48 hours exclusion criteria: * acute myocardial infarction in past 30 days acute stroke in past 30 days vv ecmo va ecmo

Keywords: covid-19
comparison of the effects on promoting corneal epithelial wound healing between human auto-serum and cord blood serum

Conditions: Eye Injuries

Summary: human serum eye drops have been successfully used in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing. umbilical cord serum is also proven to be effective in treatment of dry eye and persistent corneal epithelial defects. however, there are limited studies comparing the corneal epithelial wound healing promoting effects between these two blood derived products. the purpose of this study is to test the corneal epithelial wound healing promoting effects between auto serum and human cord blood serum. primary cultured bovine corneal epithelial cells were used as the model to investigate wound healing, cell proliferation and migration by means of scratch corneal wound healing assay evaluation, mts assay and boyden chamber migration assay in response to human serum and umbilical cord serum. the concentrations of egf, tgf-β1, and fibronectin were also compared between human serum and umbilical cord serum with elisa kits.

human serum eye drops have been successfully used clinically in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing. umbilical cord serum is also proven to be effective in treatment of dry eye and persistent corneal epithelial defects. however, there are limited studies comparing the corneal epithelial wound healing promoting effects between these two blood derived products. the purpose of this study is to test the corneal epithelial wound healing promoting effects between auto serum and human cord blood serum. primary cultured bovine corneal epithelial cells were used as the model to investigate wound healing, cell proliferation and migration by means of scratch corneal wound healing assay evaluation, mts assay and boyden chamber migration assay in response to human serum and umbilical cord serum. the concentrations of egf, tgf-β1, and fibronectin were also compared between human serum and umbilical cord serum with elisa kits.

Eligibility criteria:
inclusion criteria: healthy volunteers exclusion criteria: unhealthy volunteers

Keywords: corneal epithelium